Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine

A Phase 3, Multicenter, Randomized, Open-label Study to Evaluate the Long-term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine

This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.

Study Overview

• Status: Completed
• Conditions: Episodic Migraine
• Intervention / Treatment: Drug: Standard of Care (SOC) Migraine Preventive Medication; Drug: Atogepant

• Study Type: Interventional
• Enrollment (Actual): 744
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research, LLC
    • Birmingham, Alabama, United States, 35211
      • Clinical Research Advantage, Inc./Simon Williamson Clinic, PC
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Synexus Clinical Research US, Inc./East Valley Family Physicians PLC
    • Mesa, Arizona, United States, 85213
      • Synexus Clinical Research US, Inc./Desert Clinical Research, LLC
    • Phoenix, Arizona, United States, 85020
      • Synexus Clinical Research US, Inc./Central Phoenix Medical Clinic, LLC
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • Imperial, California, United States, 92251
      • Sun Valley Research Center, Inc.
    • Irvine, California, United States, 92614
      • Irvine Center for Clinical Research
    • La Mesa, California, United States, 91942
      • Grossmont Center for Clinical Research
    • Lemon Grove, California, United States, 91945
      • Synergy San Diego
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, LLC.
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Oakland, California, United States, 94607
      • Pacific Research Partners, LLC
    • Oceanside, California, United States, 92056
      • Excell Research, Inc.
    • Redlands, California, United States, 92374
      • Desert Valley Research
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92123-1881
      • California Research Foundation
    • San Marcos, California, United States, 92078
      • Artemis Institute for Clinical Research
    • Santa Monica, California, United States, 90404
      • California Medical Clinic for Headache
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Vista, California, United States, 92083
      • Synexus Clinical Research US, Inc.
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Delta Waves, Inc.
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurosciences Research, LLC
  • Florida
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical
    • Hollywood, Florida, United States, 33024
      • Infinity Clinical Research
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
    • Maitland, Florida, United States, 32751
      • Meridien Research
    • Miami, Florida, United States, 33173
      • Well Pharma Medical Research, Corp.
    • Ocoee, Florida, United States, 34761
      • Sensible Healthcare LLC
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc
    • Orlando, Florida, United States, 32806
      • Bioclinica Research
    • Sunrise, Florida, United States, 33351
      • Infinity Clinical Research LLC
    • Tampa, Florida, United States, 33634
      • Meridien Research
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Synexus Clinical Research US, Inc.
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center For Clinical Research
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston Premier Healthcare Research LLC
  • Kansas
    • Lenexa, Kansas, United States, 66214
      • MidAmerica Neuroscience Research Foundation dba Rowe Neurology Institute
    • Overland Park, Kansas, United States, 66211
      • Kansas Institute of Research
    • Prairie Village, Kansas, United States, 66208
      • Phoenix Medical Research, Inc.
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric Research
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • New Orleans Center for Clinical Research
  • Massachusetts
    • Marlborough, Massachusetts, United States, 01752
      • Community Clinical Research Network
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Headache & Neurological Institute
    • Kalamazoo, Michigan, United States, 49009
      • Beyer Research
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute, Inc.
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Olive Branch Family Medical Center
  • Missouri
    • Springfield, Missouri, United States, 65810
      • Clinvest
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research, LLC
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research, LLC
    • Omaha, Nebraska, United States, 68144
      • Synexus Clinical Research US, Inc
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea Research Institute
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institutes
    • Raritan, New Jersey, United States, 08869
      • Amici Clinical Research
    • Skillman, New Jersey, United States, 08558
      • Princeton Center for Clinical Research
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center
    • Endwell, New York, United States, 13760
      • Regional Clinical Research, Inc.
    • Jamaica, New York, United States, 11432
      • Synexus Clinical Research US, Inc.
    • Manlius, New York, United States, 13104
      • Central New York Clinical Research
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates, LLC
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Plains Clinical Medical Clinic, LLC
  • Ohio
    • Akron, Ohio, United States, 44311
      • Synexus Clinical Research US, Inc.
    • Cincinnati, Ohio, United States, 45236
      • Synexus Clinical Research US, Inc.
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research, Inc.
    • Willoughby Hills, Ohio, United States, 44094
      • Ohio Clinical Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73106
      • IPS Research Company
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network
    • Salem, Oregon, United States, 97301
      • Oregon Center for Clinical Investigations, Inc.
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Of Philadelphia, Llc
    • Scottdale, Pennsylvania, United States, 15683
      • Frontier Clinical Research, LLC
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research, LLC
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research, Inc.
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Meridian Clinical Research, LLC
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Volunteer Research Group
    • Memphis, Tennessee, United States, 38119
      • CNS Healthcare - Memphis
    • Tullahoma, Tennessee, United States, 37388
      • Trinity Clinical Research
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc
    • Bryan, Texas, United States, 77802
      • DiscoveResearch, Inc.
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LP
    • Houston, Texas, United States, 77058
      • Earle Research
    • Humble, Texas, United States, 77338
      • Research Trials Worldwide, LLC
    • San Antonio, Texas, United States, 78229
      • Synexus Clinical Research US, Inc.
    • Waxahachie, Texas, United States, 75165
      • ClinPoint Trials
  • Utah
    • Draper, Utah, United States, 84020
      • J. Lewis Research, Inc./Foothill Family Clinic Draper
    • Ogden, Utah, United States, 84403
      • Advanced Research Institute
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research Center, LLC
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Associates of Tidewater
    • Virginia Beach, Virginia, United States, 23454
      • Tidewater Integrated Medical Research
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Seattle, Washington, United States, 98105
      • Seattle Women's: Health, Research
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • SSM Dean Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
• Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment.
• Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
• At least a 1-year history of migraine with or without aura consistent with a diagnosis
• Age of the participant at the time of migraine onset < 50 years
• History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

Exclusion Criteria:

• Difficulty distinguishing migraine headaches from tension-type or other headaches
• Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
• Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy
• ≥ 15 headache days per month on average across the 3 months prior to Visit 1
• Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
• Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test
• Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease
• Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of mercury (mm Hg) or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once.
• At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
• History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral SOC Migraine Preventive Medication; Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.	Drug: Standard of Care (SOC) Migraine Preventive Medication; Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.
Experimental: Atogepant 60 mg; Atogepant 60 mg tablet taken orally, once daily for 52 weeks.	Drug: Atogepant; Atogepant tablets taken orally, once daily for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.	From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator	Laboratory tests included tests of hematology, chemistry, and urinalysis. The investigator determined if the results were potentially clinically significant (PCS). Only categories with at least one participant are reported.	From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator	A standard 12-lead ECG was performed. The investigator determined if the result was potentially clinically significant. Only categories with at least one participant are reported.	Up to Week 52
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator	Vital sign measurements included sitting and standing blood pressure (BP), sitting and standing pulse rate, respiratory rate, temperature, and body weight. The investigator determined if the results were clinically significant. Only categories with at least one participant are reported.	From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up)
Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior	The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior). Only the most severe suicidal ideation and the most severe suicidal behavior counted during the treatment period for at least 1 participant are reported.	Up to Week 52

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4.
• Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): May 21, 2020
• Study Completion (Actual): May 21, 2020

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 3101-302-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No